Tuesday, December 07, 2010

In a decision released moments ago, the D.C. Circuit Court of Appeals upheld a district court's preliminary injunction against the FDA, enjoining the Agency from regulating electronic cigarettes as drug-device combinations under the U.S. Food, Drug, and Cosmetic Act (FDCA). Instead, the FDA may regulate electronic cigarettes as "tobacco products" under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act).

The Court's decision accepted the basic reasoning I and others put forward in an amicus brief to the Court, in which we argued that the FDA may not regulate NJOY's electronic cigarettes as drug delivery devices under the Food, Drug and Cosmetic Act (FDCA) because to be considered a drug delivery device, a tobacco product must be marketed with a therapeutic or medicinal claim.

In our amicus brief, we argued that: "the FDA’s interpretation of “tobacco products” is unreasonably narrow, particularly when considered in light of the Tobacco Act, which defines “tobacco product” expansively as “any product made or derived from tobacco that is intended for human consumption . . . .” The notion that NJOY’s e-cigarettes, which undisputedlycontain nicotine distilled from tobacco plants, are not “tobacco products,” and thus exempted from regulation under the FDCA, is both illogical and contrary to the unambiguous intent of Congress. The FDA’s novel and far-reaching theory of FDCA jurisdiction should be rejected."

The Court's decision also accepted our argument that the FDA is incorrect in asserting that an injunction on its enforcement of a ban on electronic cigarettes will endanger the public's health.

The Rest of the Story

The basic reasoning of the Court is that in Brown & Williamson, the Supreme Court ruled that tobacco products - as a broad class - could not be regulated under the FDCA absent claims of therapeutic effect. In other words, as customarily marketed, tobacco products could not be regulated as drugs/devices by the FDA.

Quoting from Brown & Williamson, the Court emphasized that "what Congress ratified was the FDA's plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed."

The Court also held that in Brown & Williamson, the Supreme Court was not just talking about cigarettes and smokeless tobacco, it was talking about all tobacco products.

The Court argues: "For our purposes, the central question is whether Brown & Williamson's reading of the FDA's authority under the drug/device provisions of the FDCA applies only to tobacco products for which Congress has passed specific regulatory statutes or whether it extends to all tobacco products as customarily marketed. ... we think the better reading is that the FDA lacks FDCA drug/device authority to regulate all tobacco products marketed without claims of therapeutic effect, i.e., as customarily marketed."

Furthermore, the Court emphasized that the Tobacco Act explicitly states that it does not expand the FDA's jurisdiction to regulate products under the FDCA.

The Court argues that: "The Tobacco Act itself states that it does not 'affect, expand, or limit' the FDA's jurisdiction to regulate products under the drug/device provisions of the FDCA, and the district court and parties themselves appear to agree that the Tobacco Act did not expand the category of drugs, devices, and combination products subject to FDCA jurisdiction in the wake of Brown & Williamson."

The Court emphasizes that the Tobacco Act defines tobacco products to include "any product made or derived from tobacco." Thus, it defines electronic cigarettes as tobacco products. But because the Tobacco Act does not extend FDA's jurisdiction under FDCA, and the FDA did not regulate electronic cigarettes prior to the Tobacco Act, the Agency cannot now assert jurisdiction over electronic cigarettes under FDCA.

The Court expressed its basic conclusion as follows: "Together, Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCA's drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under those provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act."

Thus, if the FDA accepts the Court's decisions, it will have to regulate electronic cigarettes as tobacco products under the Tobacco Act, rather than as drug/device combinations under FDCA.

The Appeals Court also rejected the FDA's argument that enjoining it from regulating electronic cigarettes as drug/device combinations under FDCA would harm the public's health.

The Court stated: "Regarding harm to third parties and to the public interest, the district court observed that the FDA had cited no evidence to show that electronic cigarettes harmed anyone." The Appeals Court accepted the district court's finding on this issue.

The Appeals Court decision was rendered by a three-judge panel. Interesting, one of the three judges, while concurring in the ultimate decision, did so for different reasons. Judge Garland opined that Brown & Williamson does apply only to cigarettes and smokeless tobacco products, not to all nicotine-containing products. However, he goes on to argue that under the Tobacco Act, electronic cigarettes are clearly defined as tobacco products because they are derived from tobacco.

As Judge Garland states: "Because the nicotine in NJOY's electronic cigarettes is "derived from" natural tobacco, it appears that the FDA may regulate it only pursuant to the provisions of the Tobacco Control Act."

Judge Garland concludes: "I conclude that, unless a product derived from tobacco is marketed for therapeutic purposes, the FDA may regulate it only under the provisions of the Tobacco Control Act."

What is Next?

This decision means that the FDA must desist from denying the entry of electronic cigarettes into the United States and from regulating these products as drug/device combinations under the FDCA. However, the FDA could still potentially issue a new regulation in which it interprets electronic cigarettes as being drug/device combinations under the Tobacco Act. Should that happen, the courts would have to consider anew whether the Agency has such authority.

A more likely possibility is that the FDA will appeal the decision to the Supreme Court. A final possibility is that the Agency will simply accept the Appeals Court's decision and regulate electronic cigarettes as tobacco products under the Tobacco Act.

Implications of the Decision

While by no means the final disposition of this issue, the Appeals Court's decision is important, because it gives us a fair indication that the courts are likely to interpret the Tobacco Act and Brown & Williamson decision in exactly the way that I argued in my amicus brief: electronic cigarettes are clearly defined as tobacco products, and absent any therapeutic claims, must be regulated as tobacco products under the Tobacco Act rather than as drug/device combinations under the FDCA.

Ultimately, I believe this would be in the best interests of the public's health. Electronic cigarettes appear to be a much safer product than regular cigarettes and there is strong anecdotal evidence that they are helping many people to successfully quit smoking. Thus, they truly have life-saving potential. While regulation of the marketing claims, access to minors, and other aspects of electronic cigarettes are appropriate and will help assure consumers of their relative safety, allowing these products to remain on the market enables the public to take advantage of this unique innovation. Removing them from the market, as would essentially be required if they were regulated under FDCA, would cause irreparable harm to thousands of ex-smokers who would be forced to return to smoking if the electronic cigarettes they have used to successfully quit smoking were no longer available.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.